Stéphane Bancel, Moderna CEO (Adam Glanzman/Bloomberg via Getty Images)

UP­DAT­ED: Mod­er­na says Covid-19 boost­ers stand a fight­ing chance against new vari­ants

A day be­fore its sec­ond an­nu­al Vac­cines Day, Mod­er­na has post­ed an up­date on its crown jew­el, in­clud­ing a 6-month look at the Covid-19 shot and new pre­clin­i­cal da­ta that sug­gest its boost­er can­di­dates stand a fight­ing chance against new vari­ants.

Mod­er­na’s vari­ant-spe­cif­ic boost­er mR­NA-1273.351, which was de­signed to tar­get the B.1.351 mu­ta­tion first iden­ti­fied in South Africa, “closed the neu­tral­iz­ing titer gap for vari­ants of con­cern” in mice, the com­pa­ny said on Tues­day af­ter­noon. When giv­en at the 6-month mark, the boost­er elicit­ed neu­tral­iz­ing titers against the vari­ant that were com­pa­ra­ble to those pro­duced against the orig­i­nal virus.

mR­NA-1273.211, a com­bi­na­tion of mR­NA-1273.351 and Mod­er­na’s al­ready au­tho­rized vac­cine, al­so in­creased neu­tral­iz­ing titers against vari­ants ac­cord­ing to the pre­clin­i­cal re­sults, which have been sub­mit­ted to bioRx­iv but haven’t been pub­lished.

“The new pre­clin­i­cal da­ta on our vari­ant-spe­cif­ic vac­cine can­di­dates give us con­fi­dence that we can proac­tive­ly ad­dress emerg­ing vari­ants,” CEO Stéphane Ban­cel said in a state­ment. “Mod­er­na will make as many up­dates to our COVID-19 vac­cine as nec­es­sary un­til the pan­dem­ic is un­der con­trol.”

Ban­cel told End­points News that he ex­pects the virus to mu­tate very quick­ly in the next cou­ple years, be­cause a lot of peo­ple haven’t yet been vac­ci­nat­ed or in­fect­ed. Then in 2023 or 2024, he pre­dicts the speed at which the vac­cine mu­tates could slow down.

“We think that in the next two years, there might be a need for sev­er­al boosts, es­pe­cial­ly for peo­ple at high risk,” he said. “We think over time, maybe a boost per year might be enough, es­pe­cial­ly if com­bined with your flu boosts.”

As for the orig­i­nal vac­cine, an up­dat­ed re­view of 900-plus Covid-19 cas­es from the Phase III COVE study con­firms the jab is more than 90% ef­fec­tive against all cas­es, and over 95% ef­fec­tive against se­vere cas­es. A study with 33 Phase I par­tic­i­pants showed that an­ti­bod­ies per­sist­ed 6 months af­ter the sec­ond dose, ac­cord­ing to re­sults pub­lished in the New Eng­land Jour­nal of Med­i­cine. Mod­er­na be­lieves ef­fi­ca­cy kicks in two weeks af­ter the sec­ond dose.

As part of its own up­dat­ed re­view, Pfiz­er said its BioN­Tech-part­nered jab demon­strat­ed “strong pro­tec­tion” 6 months af­ter the sec­ond dose, with an over­all ef­fi­ca­cy rate of 91.3%.

Mod­er­na’s Phase II/III Teen­COVE study is ful­ly en­rolled with about 3,000 par­tic­i­pants be­tween the ages of 12 and 17 in the US, ac­cord­ing to the com­pa­ny. That tri­al will as­sess a 100 µg dose of the vac­cine. Mean­while, the Phase II/III Kid­COVE study is still re­cruit­ing chil­dren be­tween 6 months and 11 years old. Mod­er­na hopes to en­roll 6,750 healthy par­tic­i­pants in the US and Cana­da for the two-part dose es­ca­la­tion study. In Part 1, chil­dren be­tween the ages of 2 and 12 will re­ceive ei­ther 50 μg or 100 μg of the vac­cine, and those who are younger will be giv­en one of three dose lev­els — 25 μg, 50 μg or 100 μg. An in­ter­im analy­sis will de­ter­mine which dose is used in Part 2.

The news comes as the US paus­es the roll­out of J&J’s vac­cine to re­view da­ta around six re­port­ed cas­es of a rare and se­vere type of blood clot. The CDC’s Ad­vi­so­ry Com­mit­tee on Im­mu­niza­tion Prac­tices is meet­ing to­mor­row to fur­ther re­view these cas­es and as­sess their po­ten­tial sig­nif­i­cance.

The EMA re­port­ed 3 cas­es of cere­bral ve­nous si­nus throm­bo­sis among the 4.5 mil­lion peo­ple vac­ci­nat­ed with J&J’s shot world­wide. By com­par­i­son, 169 cas­es of CVST and 53 cas­es of splanch­nic vein throm­bo­sis were re­port­ed among 34 mil­lion peo­ple who re­ceived the As­traZeneca vac­cine in the EEA and UK. Thir­ty-five CVST cas­es were found world­wide among those who have re­ceived the Pfiz­er shot, and 5 for Mod­er­na.

“A com­pre­hen­sive as­sess­ment of the to­tal­i­ty of the avail­able safe­ty da­ta for mR­NA-1273 af­ter over 64.5 mil­lion dos­es ad­min­is­tered glob­al­ly does not sug­gest an as­so­ci­a­tion with CVST or throm­bot­ic events, based on analy­ses per­formed us­ing da­ta through March 22, 2021,” Mod­er­na said in a state­ment.

The CDC has is­sued a state­ment that its Vac­cine Ad­verse Event Re­port­ing Sys­tem “has re­ceived no re­ports of CVST with throm­bo­cy­tope­nia among per­sons who re­ceived ei­ther of the two mR­NA-based COVID-19 vac­cines.”

As of April 12, Mod­er­na had shipped out 132 mil­lion dos­es world­wide, in­clud­ing about 117 mil­lion to the US. Rough­ly 88 mil­lion dos­es were de­liv­ered to the US in Q1, in ad­di­tion to about 14 mil­lion else­where. Plans are in place to ramp up the com­pa­ny’s ex-US sup­ply chain.

Mod­er­na says it’s on track to de­liv­er 100 mil­lion dos­es to the US by the end of May, and an­oth­er 100 mil­lion by the end of Ju­ly.

For a look at all End­points News coro­n­avirus sto­ries, check out our spe­cial news chan­nel.

How Pa­tients with Epilep­sy Ben­e­fit from Re­al-World Da­ta

Amanda Shields, Principal Data Scientist, Scientific Data Steward

Keith Wenzel, Senior Business Operations Director

Andy Wilson, Scientific Lead

Real-world data (RWD) has the potential to transform the drug development industry’s efforts to predict and treat seizures for patients with epilepsy. Anticipating or controlling an impending seizure can significantly increase quality of life for patients with epilepsy. However, because RWD is secondary data originally collected for other purposes, the challenge is selecting, harmonizing, and analyzing the data from multiple sources in a way that helps support patients.

Jason Kelly, Ginkgo Bioworks CEO (Kyle Grillot/Bloomberg via Getty Images)

UP­DAT­ED: Gink­go Bioworks re­sizes the de­f­i­n­i­tion of go­ing big in biotech, rais­ing $2.5B in a record SPAC deal that weighs in with a whop­ping $15B-plus val­u­a­tion

Ginkgo Bioworks execs always thought big. But today should redefine just how big an upstart biotech player can dream.

In the largest SPAC deal to clear the hurdles to Nasdaq, the biotech that envisioned everything from remaking synthetic meat to a whole new approach to developing drugs has joined forces with one of the biggest disruptors in biotech to slam the Richter scale on dealmaking.

Soon after becoming the darling of the VC crew and clearing the bar on a $4 billion valuation, Ginkgo — a synthetic biotech player out to reprogram cells with industrial efficiency — has now struck a deal to go public in the latest leviathan SPAC that sets its pre-money valuation at $15 billion. In one swift vault, Ginkgo will combine with Harry Sloan’s Soaring Eagle Acquisition Corp. and leap into the public markets.

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FDA un­veils six ICH guide­lines ahead of meet­ing with Health Cana­da

A sign that the FDA’s non-Covid-related processes are beginning to normalize: The release of six guidelines from the International Council of Harmonisation.

Years in development, the ICH documents offer an international perspective on drug development, with these latest guidelines covering everything from recommendations to support the classification of drug substances, featured in the M9 guidance, to standards for nonclinical safety studies for pediatric medicines in the S11 guideline.

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Sanofi, Glax­o­SmithK­line, Boehringer ac­cused of play­ing games, de­stroy­ing emails re­lat­ed to law­suit over con­t­a­m­i­nat­ed Zan­tac

A recent court filing raises new questions about how major pharma companies like Sanofi, GlaxoSmithKline, and Boehringer Ingelheim have dealt with a lawsuit related to recalls of certain over-the-counter heartburn drugs due to the presence of a potentially cancer-causing substance found in them.

More than 70,000 people who took Sanofi’s Zantac and other heartburn drugs containing ranitidine, which have been recalled over the past two years, have sued the manufacturers, including generic drugmakers, and other retailers and distributors as part of a consolidated suit before US District Court Judge Robin Rosenberg in Florida.

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Alvotech takes Ab­b­Vie to court over al­leged patent 'mine­field' sur­round­ing megablock­buster Hu­mi­ra

AbbVie has so far been successful in shooing away competition to its megablockbuster Humira, deploying a number of patents and settlements to keep biosimilars off the US market until 2023. But one Icelandic drugmaker doesn’t want to wait — and on Tuesday, it filed a lawsuit challenging what it called a patent “minefield.”

Alvotech has accused AbbVie of trying to “overwhelm” and “intimidate” it with “an outrageous number of patents of dubious validity,” according to court documents. The company is currently seeking approval for its Humira copycat AVT02, which AbbVie says would infringe upon 62 patents.

UP­DAT­ED: Feds charge an­oth­er CRO staffer with fak­ing da­ta in a Glax­o­SmithK­line pe­di­atric asth­ma study

A Florida woman has been indicted as part of a clinical trial fraud scheme over a GlaxoSmithKline pediatric asthma study, the Justice Department announced Tuesday, the latest development in a case where three individuals have already pleaded guilty.

Jessica Palacio was charged with participating in a plot to falsify medical records, giving off the appearance that trial participants were making their scheduled visits to a Miami CRO and taking an experimental asthma medication as required. Palacio was also charged with lying to FDA investigators about her conduct.

Albert Bourla, Pfizer CEO (Gian Ehrenzeller/Keystone via AP Images)

Covid-19 roundup: Pfiz­er CEO Bourla to write book about vac­cine arms race; Chi­nese mR­NA shot set for PhI­II tri­al in Mex­i­co

Pfizer CEO Albert Bourla has inked a deal with Harper Business for a book to tell the “behind-the-scenes” story of the company’s race to develop a vaccine, the Associated Press reports.

The book is titled “Moonshot: Inside Pfizer’s Nine-Month Race to Make the Impossible Possible” and is set to be released Nov. 9. Bourla plans to donate the proceeds to charity, the AP reported.

Al Sandrock, Biogen R&D chief (Biogen via YouTube)

UP­DAT­ED: Bio­gen push­es in a fresh stack of chips and starts prep­ping a glob­al R&D game plan af­ter watch­ing the cards turn on ear­ly throm­bolyt­ic da­ta

After patiently steering through a decade-long journey for its early-stage clinical work, a small Tokyo biotech has clinched a deal to out-license its lead thrombolytic agent to US heavyweight Biogen — which sees a potentially game-changing impact on the clot-busting field after taking a careful look at some upbeat Phase IIa data.

Three years after Biogen anted up $4 million to gain an option on the drug from TMS, the big US biotech is making a small bet to beef up its stroke portfolio. The BD team inked a deal to go ahead and grab rights to the drug for $18 million, with another $335 million in milestone cash on the table for a successful outcome.

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Chris Garabedian (Xontogeny)

Per­cep­tive Ad­vi­sors, Xon­toge­ny bring the band back and then some with a $515M sec­ond fund sniff­ing out lead com­pounds

When Perceptive Advisors and startup accelerator Xontogeny initially teamed up on an early-stage VC round in 2019, the partners hoped to prove their investments could be a force multiplier for early-stage companies. Now, with that proof of concept behind them, the pair have closed a second VC round worth more than double the money.

Dubbed PXV Fund II and headed by Xontogeny CEO and former Sarepta head Chris Garabedian, the $515 million fund will target 10 to 12 early-stage preclinical companies with Series A rounds in the $20 million to $40 million range with opportunities for Series B follow-ups. The oversubscribed fund is bringing the band back with initial investors from PXVI as well as new investors that include “top-tier” asset managers, endowments, foundations, family offices, and individual investors.

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